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Not yet recruiting NCT07574918

Measuring Nasal Airway Changes After VivAer Treatment Using AI Analysis

No phase Interventional Nasal Airway Obstruction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: VivAer Stylus.
Who it may be relevant to
Registry conditions: Nasal Airway Obstruction. Basic parameters: 22 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Quantitative Evaluation of Nasal Airway Remodeling Following Temperature-Controlled Radiofrequency Treatment for Nasal Airway Obstruction Using AI-Assisted Analysis (BREATHE AI)

Overview

The goal of this clinical trial is to measure changes in the nasal airway after treatment with the VivAer® procedure in adults aged 22 to 85 with nasal airway obstruction caused by nasal valve dysfunction. The main questions it aims to answer are: Are there measurable changes in the nasal airway and airflow after treatment with the VivAer procedure? Participants will: Undergo the VivAer procedure, which uses radiofrequency energy to remodel tissue in the nasal valve area. Have endoscopic images of their nasal airway taken before treatment and at follow-up visits at 3 and 6 months after treatment, which will be analyzed using the VISIONAIR™ AI System. They will complete symptom and quality of life surveys at each visit, including the Nasal Obstruction Symptom Evaluation (NOSE) Scale, the STOP-BANG Sleep Score, and the Short-Form (SF-12) Health Survey.

Interventions

  • Device VivAer Stylus
    Bipolar radiofrequency energy delivered to the lateral nasal wall at the upper lateral cartilage using the VivAer® Stylus and Aerin Console at device default settings (temperature 60°C, power 4 watts, treatment time 18 seconds, cooling time 12 seconds) to remodel submucosal tissue, including cartilage, in the internal nasal valve area.

Primary outcome measures

  • Change in nasal valve angle and cross-sectional area [Time frame: Baseline to 3- and 6-months post-procedure.]

Eligibility criteria

Inclusion criteria

  • Age 22 to 85 years old (inclusively).
  • Willing and able to provide consent.
  • Willing and able to comply with the patient-specific requirements and follow-up schedule outlined in the study protocol.
  • Has a NOSE Score of ≥ 55.
  • Has a documented diagnosis of NAO with NVC (static or dynamic) as the primary driver of NAO symptoms.
  • Has a documented positive Modified Cottle Maneuver (using curette or equivalent to perform maneuver and evaluate nasal valve function).

Exclusion criteria

  • Has had rhinoplasty, septoplasty, inferior turbinate reduction or functional endoscopic surgery (FESS) within the preceding 3 months.
  • Has uncontrolled chronic rhinitis as a contributor to nasal obstruction symptoms.
  • Has a complex nasal anatomy (e.g., anatomical deformity) or a history of significant nasal trauma that is a potential contributor to nasal obstruction symptoms.
  • Has any intranasal conditions that preclude adequate visualization of the nasal valve area.
  • Has a medical condition(s) that may impair normal healing processes.
  • Any adjunctive surgical or other nasal procedure (e.g., concha bullosa resection, inferior turbinate out fracture, septoplasty, etc.) on the same day or planned within 6 months of the study procedure.
  • Has current or recent (within 30 days prior to screening) exposure to oral systemic corticosteroids or is expected to require oral corticosteroid therapy during the course of the study.
  • Has nasal polyps, or a history of nasal polyps requiring medical or surgical treatment within the past 12 months.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07574918 · CTP2527

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗